Clinical performance of a new levonorgestrel-releasing intrauterine device. A randomized comparison with a nova-T-copper device.
The clinical performance of two levonorgestrel-releasing intrauterine devices (IUDs) with different release rates was studied and compared with a copper-releasing Nova-T device in a randomized partly double-blind multiclinical trial. Special attention was given to patterns of bleeding, hormonal side-effects, blood pressure and body weight. The clinical acceptability of the levonorgestrel IUDs was as good as that of the copper-releasing IUD. A highly significant decrease in the amount of menstrual blood loss was seen with the levonorgestrel-IUDs, the users of which experienced fewer days of bleeding than prior to insertion. Patients suffering from dysmenorrhea experienced relief from this symptom after insertion of a levonorgestrel-IUD. Some side-effects, usually referred to as hormonal, increased during the levonorgestrel-IUD use, but did not result in higher termination rates than with the Nova-T device. No changes in body weight were recorded for the levonorgestrel-IUDs and a slight decrease in both systolic and diastolic blood pressure was found after one year of use. No infections were recorded.
D000293:Adolescent; D000328:Adult; D000568:Amenorrhea / Q000209:etiology; D001794:Blood Pressure / Q000187:drug effects; D001835:Body Weight / Q000187:drug effects; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007434:Intrauterine Devices / Q000009:adverse effects; D007435:Intrauterine Devices, Copper / Q000009:adverse effects; D016912:Levonorgestrel; D008598:Menstruation / Q000187:drug effects; D009644:Norgestrel / Q000008:administration & dosage* / Q000009:adverse effects; D011897:Random Allocation
D009644:Norgestrel; D016912:Levonorgestrel